Bioheng Biotech received Orphan Drug Designation from the U.S. FDA for the treatment of T-ALL.

New approval for treating leukomia

Nanjing Bioheng Biotech Co., Ltd. Announced UCAR T cell therapy product targeting CD7, code CTD401, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia (T-ALL).

"CTD401 is the first innovative product based on our next-generation generic CAR-T technology platform. It has excellent efficacy and superior safety in exploratory clinical studies," said Dr. JiangTao Ren, Co-founder and Chief Scientific Officer of Bioheng, "Orphan drug accreditation not only reflects the confidence of the international authority FDA on CTD401, but also is an important milestone of Bioheng gradual globalization."

CTD401 is a universal CAR-T (UCAR-T) cell therapy product developed by Bioheng for the treatment of patients with T-ALL. The product is prepared by collecting peripheral blood mononuclear cells (PBMC) from healthy donors, using a virus encoding a CD7 CAR gene for transduction, and using CRISPR/cas9 technology to knock out key genes.

Tags : #TCell #TAll #Leukomia #BiohengBiotech #FDAApproval #FDA #FDANews

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-



Trending Now

Why is Early Intervention (EI) so important for autism?November 30, 2022
Heart failure – Symptoms, risk factors, and treatmentNovember 30, 2022
How to consume Bulletproof coffee for weight loss?November 30, 2022
MedySeva Gives New Dimension to Affordable TelehealthNovember 29, 2022
A mental healthcare revolution with Trijog November 29, 2022
Health Basix – In-school healthcare partner for your kidsNovember 28, 2022
Health-tech startup Healthkart raises Rs 536.52 Crore led by TemasekNovember 28, 2022
TummyFriendly Foods – Harmless Bio-available nutrition for little onesNovember 28, 2022
Causes, Symptoms, and Solutions to Lung Cancer November 28, 2022
5 reasons behind premature hair grayingNovember 26, 2022
Connect2MyDoctor’s cARe - Augmented Reality tool playing a crucial role in patient educationNovember 26, 2022
Bollywood Actor Kajal Aggarwal invests in D2c Startup TACNovember 26, 2022
Causes, Symptoms, Treatment, and Preventive Solutions for Ovarian Cancer November 26, 2022
Men’s health firm Bonatra raises Rs 5.5 Cr in the pre-seed funding roundNovember 25, 2022
Why is Samantha Ruth Prabhu hospitalized again in Hyderabad?November 25, 2022
RedBrick AI, a Healthtech startup, raises $4.6 million in funding from Sequoia India, Surge.November 25, 2022
Now schedule your health check-ups at a much-discounted price with MediWheelNovember 24, 2022
Kamal Haasan gets admitted to Chennai Hospital Today November 24, 2022
India's first Global Women's Health Innovation Conference to highlight the potential of Femtech & Digital InnovationsNovember 24, 2022
Pred Health - HealthTech Startup dedicated to provide Integrated care management for cancer patientsNovember 24, 2022